Predictors of Rupture Risk of Intracranial Aneurysms

NCT04613427 | Completed

• 1 other identifier: RAPID
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients admitted to Haukeland University Hospital with either UIA or aSAH underwent a measurement of bioelectrical impedance and body mass composition using InBody 10. Lipids and lipoproteins were collected from plasma. 60 patients in total were included in the study.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Anthropometric risk factors of ruptured versus unruptured intracranial aneurysms

  The case group with SAH patients will be compared to the control group with UIA patients. The anthropometric variables is measured by InBody S10 and includes BMI, waist circumference, visceral fat area, body fat mass, body fat percentage, fat free mass, and skeletal muscle mass. The waist/height ratio will be calculated. The data will be analyzed by generalized linear modeling (logistic regression), and the models will be controlled for prognostic factors, including sex, age, hypertension, smoking, alcoholism, statin use, family history of SAH, aneurysm size, diabetes, and cardiovascular disease.

  The anthropometric data will be collected within 96 hours after admittance, as well as information on the predictors and risk factors from the patient journal.

Secondary Outcomes (5)

• Standard lipid risk factors of ruptured versus unruptured intracranial aneurysms

  Blood samples collection within 96 hours after admittance. Calculations will be performed within 3 years after study completion (June 2022).

• Lipid ratios as risk factors of ruptured versus unruptured intracranial aneurysms

  The calculations will be performed prior to statistical analyses within 3 years after study completion (June 2022).

• Apolipoprotein risk factors of ruptured versus unruptured intracranial aneurysms

  Blood samples collection within 96 hours after admittance.

• Apolipoprotein A1/B ratio as a risk factor of ruptured versus unruptured intracranial aneurysms

  Calculations will be performed within 3 years after study completion (June 2022).

• Lipoprotein subclass risk factors of ruptured versus unruptured intracranial aneurysms.

  Blood samples collection within 96 hours after admittance.

Study Arms (2)

Unruptured intracranial aneurysm

Patients admitted at Haukeland University Hospital in the study period for treatment of UIA.

Aneurysmal subarachnoid hemorrhage

Patients admitted at Haukeland University Hospital in the study period for treatment of aSAH.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Haukeland University Hospital with either aneurysmal subarachnoid hemorrhage or unruptured intracranial aneurysm.

You may qualify if:

• Admitted electively for treatment of unruptured intracranial aneurysm
• Admitted acutely for aneurysmal subarachnoid hemorrhage
• Informed consent form signed by patient or close relative

You may not qualify if:

• Pregnant
• Pacemaker
• Subarachnoid hemorrhage without identified aneurysmal rupture
• Unruptured aneurysm with previous SAH/intracranial hemorrhage

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5021, Norway

Location

Related Publications (1)

• Lovik K, Laupsa-Borge J, Logallo N, Helland CA. Body composition and rupture risk of intracranial aneurysms. Eur J Med Res. 2024 May 24;29(1):297. doi: 10.1186/s40001-024-01888-3.

  PMID: 38790007 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Christian A Helland, MD PhD

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: November 3, 2020
• Study Start: April 1, 2018
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-09

Locations

NO (1)